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NCT01652170 · ClinicalTrials.gov registry record

The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis

A clinical trial of Acute Appendicitis, sponsored by Venaxis.

Completed
Registry status
2,201
Enrollment target
20
Study locations

NCT01652170 is a study of Acute Appendicitis that has completed, run by Venaxis. The registered enrollment target is 2,201 participants, above the 343-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (542% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01652170, a study of Acute Appendicitis, has completed, sponsored by Venaxis.

COMPLETED
Registry status
2,201 participants
Enrollment target
20
Study locations

Study Summary

This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.

Conditions Studied

Study Locations (20)

Massachusetts

  • Newton-Wellesley Hospital - Newton
  • Baystate Medical Center - Springfield
  • South Shore Hospital - Weymouth

Ohio

  • Cincinnati Children's Hospital - Cincinnati
  • Cleveland Clinic - Cleveland
  • Nationwide Children's - Columbus

Florida

  • University of Florida, College of Medicine - Jacksonville
  • All Children's Hospital - St. Petersburg

Georgia

  • Emory-Egleston (CHOA) - Atlanta
  • Scottish Rite (CHOA) - Atlanta

Michigan

  • University of Michigan, Mott Children's Hospital - Ann Arbor
  • Spectrum Health System - Grand Rapids

Arizona

  • Phoenix Children's Hosptial - Phoenix

Arkansas

  • Arkansas Children's Hospital - Little Rock

California

  • UC Davis - Sacramento

Trial Details

FieldValue
Enrollment Target 2,201 participants
Start Date 2013-01
Est. Completion 2014-02

Sponsor

Venaxis

1 total trials

What the Registry Record Tells You About NCT01652170

The ClinicalTrials.gov registry entry for NCT01652170 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,201 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 343-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (542% higher). The listed sponsor is Venaxis, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Appendicitis appearing as the primary indexed condition, and to 0 interventions.

NCT01652170 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, Ohio, Florida.

Frequently Asked Questions

What is clinical trial NCT01652170 about?

NCT01652170 is a clinical study titled "The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis". This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in ...

What is the current status of trial NCT01652170?

This trial is currently completed. The enrollment target is 2,201 participants. The study started on 2013-01. Estimated completion is 2014-02.

What conditions does trial NCT01652170 study?

This clinical trial studies the following conditions: Acute Appendicitis.

Who is sponsoring clinical trial NCT01652170?

This trial is sponsored by Venaxis, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01652170 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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